Vacuum Therapy in Erectile Dysfunction

History

In 1874, John King, an American physician, stated that 'when there is impotency with a diminution of the size of the male organ, the glass exhauster should be applied to the part'. What he referred to was simply a vacuum device capable of producing an artificial erection. However, it failed to maintain the erection once the glass exhauster was taken off the penis.^[2] It was not until 1917, when a patent was granted to Otto Lederer for his 'surgical device to produce erection with vacuum', that the concept of a 'compression' ring to be used in conjunction with the vacuum device was introduced.^[3] Since then, several patents had been granted to modifications,^[4,5] but the credit for the popularization of VCD is generally given to a Georgian entrepreneur, Geddins D Osbon, who developed his 'youth equivalent device' in the 1960s. It was reported that he personally used the device for more than 20 years without device failure while popularizing and perfecting the device. His effort culminated in the first marketed VCD device, Erecaid,^[6] to receive the US Food and Drug Administration (FDA) approval in 1982.^[7] Despite this, the device faced strong skepticism among the medical community and patients. Instrumental in overcoming these skepticisms and popularizing the device were the early works of Nadig^[8] and Witherington^[9] in establishing its efficacy and safety profiles. It was thought to have finally gained acceptance by the medical community with Lue's commentary in the Journal of Urology: 'I recommend a vacuum constriction device to all of my patients (except those with coagulation disorders and sickle cell disease) as the initial medical option'.^[10] As more evidence emerged, the American Urological Association ultimately recommended VCD as one of three treatment alternatives for organic ED.^[1]

Devices and Mechanisms

Currently, there are over dozens of commercially available VCDs, that is, Timm Medical Technologies (Eden Prairie, MN, USA), Mission Pharmacal (San Antonio, TX, USA), Encore (Louisville, KY, USA), Mentor (Santa Barbara, CA, USA) and Post-T-Vac (Dodge City, KS, USA). All of these devices share the same basic mechanics since its original development. They all comprise three components: a vacuum cylinder, a battery or manually operated vacuum pump and constriction rings of varying sizes (Figure 1).^[11] Some of the latest models have a pressure release valve designed to prevent penile injury from excessive negative pressure.^[12] It is reported that single-handed devices are more desirable to novice users.^[13]

(Enlarge Image)

Figure 1.

Three types of human vacuum devices.

Usage begins with placing the correct constriction ring over the open end of the vacuum cylinder. A copious amount of a water-soluble lubricant is then applied to the base of the penis to create a tight seal once the vacuum cylinder is placed over. Negative pressure (100–225 mm Hg) generated either by hand or a battery-operated pump is then applied to create an artificial erection.^[14] Once the desired state of erection is achieved, the constriction ring is displaced onto the base of the penis to maintain the erect state. Variable vacuum cylinders and constriction rings are available to select for those that are most comfortable and effective. The vacuum cylinders could then be removed and the patient may have intimacy. Patients can become proficient with the device within 5 days^[15] or four practice sessions.^[9] The time required to achieve an adequate penile erection ranges from 30 s to 7 min,^[9,16] and many manufacturers advise patients to pump for 1–2 min, release and then pump again for 3–4 min.^[7]

Unlike the normal physiology of penile erection in which a complex interplay between neural inputs, vascular patency and hormonal secretion is required, tumescence from VCD resulted from passive flow of mixed venous and arterial blood.^[17,18] Broderick et al.^[17] showed by color Doppler ultrasound that the negative pressure transiently drew arterial blood into the sinusoidal spaces of the cavernosal tissues, increasing its diameter nearly two-fold. The change in diameter owed itself to both intracorporal and extracorporal distention. The constriction ring placed at the base of the penis prevented the venous outflow. Color Doppler ultrasound performed after the placement of constriction ring, however, showed no arterial inflow into the penis.^[17] Blood gas analysis showed ischemia after 30 min of applying constriction ring.^[18] This led to the recommendation that the constriction ring should not be left on for >30 min to prevent ischemic injury to the penis. Compared with naturally occurring erections, VCD-derived erections are perceived differently by both the man and their partner. The 'erection' looks dusky and feels cooler than normal, with increased volume distally, especially at the glans penis.^[7]

Cite this: Vacuum Therapy in Erectile Dysfunction—Science and Clinical Evidence - Medscape - Jul 01, 2010.

Table 1. Efficacy of VCDs
Authors	Year published	Study design	Enrollee (mean follow-up)	Results
Nadig et al.^[8]	1986	Prospective	35 (8–22 months)	>90% achieved adequate erections. 80% use regularly
Witherington^[9]	1989	Retrospective	1517 (8.6 months)	92% good erection
Sidi et al.^[16]	1990	Prospective	100 (7.9 months)	68% satisfaction rate
Cookson et al.^[32]	1993	Retrospective	216 (29 months)	70% use regularly. Quality of erection plus satisfaction >90%
Segenreich et al.^[33]	1993	Prospective	150 (25 months)	75% achieved adequate erection. >90% satisfaction rate
Blackard et al.^[34]	1993	Prospective	45 (?)	69% satisfaction rate
Meinhart et al.^[35]	1993	Prospective	74 (3 weeks)	27% satisfaction rate
Vrijhof et al.^[36]	1994	Prospective	67	50% achieved adequate erection
Baltaci et al.^[37]	1995	Retrospective	61 (12.8 months)	>80% satisfaction rate. 67% effectiveness rate
Bosshardt et al.^[18]	1995	Prospective	30 (6 months)	Quality of erection 80%
Kolettis et al.^[38]	1995	Prospective	50	56% satisfaction rate. An acceptable treatment mode for CVOD
Lewis et al.^[7]	1997	Retrospective	5847 (?)	65–83%
Dutta et al.^[39]	1999	Prospective	129 (37 months)	High attrition rate (65%). 35% satisfaction rate

Abbreviations: CVOD, corporeal veno-occlusive dysfunction; VCD, vacuum constriction device.

Table 2. Complications of VCDs
Most common	Rare
Penile discomfort/pain	Penile hematoma
Penile coldness	Penile hyper-pigmentation
Penile numbness	Penile skin necrosis
Petechia or bruising	Urethral bleeding
Ecchymosis	Peyronie's disease
Inability to ejaculate	Penile gangrene
Pain on ejaculation	Fournier's syndrome

Abbreviation: VCD, vacuum constriction device.

Table 3. Summary table of penile rehabilitation trials
Authors	Year published	Treatment regimen	Study design	Enrollee	Results
Schwartz et al.^[89]	2004	QOD PDE₅I	Prospective	21	No loss of smooth muscle in 50-mg group, gain of smooth muscle in 100-mg group
Bannowsky et al.^[90]	2008	Daily PDE₅I	Prospective, randomized control	41	Treatment group has significantly higher IIEF and higher spontaneous erection rates
Mccullough et al.^[91]	2008	Daily PDE₅I	Prospective, randomized, placebo control	54	Treatment group had higher return of rigidity, higher rate of spontaneous erections
Raina et al.^[92]	2006	Daily VED	Prospective, randomized control	109	Improved sexual satisfaction, higher rate of spontaneous erections
Köhler et al.^[93]	2007	Daily VED (10 min), immediate versus delayed	Prospective, randomized	28	Delayed use of VED did not affect sexual satisfaction once use began. No statistical significance in penile shrinkage once VED started
Montorsi et al.^[94]	1997	ICI 3 times weekly	Prospective, randomized control	30	Higher percentage of treatment group having spontaneous erections
Mulhall et al.^[95]	2005	ICI or PDE₅I to achieve erections 3 × weekly	Prospective, control	132	Treatment group had 2.7 times the rate of spontaneous erections, statistically higher IIEF scores
Nandipati et al.^[96]	2006	Daily PDE₅I and ICI 2–3 times weekly	Prospective	22	Assisted early sexual activity and satisfaction. Addition of PDE₅I allows lower dose of ICI

Abbreviations: ICI, intracorporal injection; IIEF, International Index of Erectile Function; PDE₅I, phosphodiesterase inhibitor; VED, vacuum erectile device.
Source: Hinh P and Wang R: Overview of Contemporary Penile Rehabilitation Therapies. Advances in Urology, 2008.

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